Ann: Companion Diagnostic Study Initiated with UON, page-70

Here is a trial for the FoundationOne CDx

https://clinicaltrials.gov/ct2/show/NCT02620527?term=FoundationOne&recrs=e&draw=2&rank=3

The description is:

The purpose of this study is to assess whether a new ctDNA assay developed by Foundation Medicine is able to detect genomic alterations in peripheral blood that are consistent with the genomic alterations detected in a patient's matched primary and/or metastatic tumor biopsy sample analyzed by the FoundationOne® test. Study sites will provide matched solid tumor and peripheral blood samples of cancer patients to FMI for the purpose of testing the concordance of the FMI ctDNA assay to the FoundationOne® test. Participation in this study is part of a broader 2000 patient study to determine which tumor types are most readily measured via ctDNA profiling, and to learn of the similarity between the alterations found in a patient's tumor biopsy and the ctDNA from their blood.​

It has the following two primary outcome measures:

1. Whether new ctDNA assay can detect genomic alterations in peripheral blood that are consistent with those detected by FoundationOne in matched solid tumor samples [ Time Frame: 6-12 months ]
2. Determine which tumor types are most amenable to detection using peripheral blood ctDNA assay [ Time Frame: 6-12 months ]